NCT03535558

Fluoroquinolone Associated Disability

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 239,306 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to: 1) describe drug utilization for Fluoroquinolone(FQ), Azithromycin (AZ) and Sulfamethoxazole/Trimethoprim(ST) in the entire Truven MarketScan Commercial Claims and Encounters database (CCAE) database, and specifically among individuals in the Health and Productivity Management (HPM) during the observation period; 2) describe the rate of disability associated with 2 or more System Organ Class adverse events (SOC AEs) and exposure to FQs for several acute, uncomplicated indications; and 3) compare the rates of disability for 2 or more SOC AEs and exposure to FQs and AZ/ST for the same indications.

Conditions

• Bronchitis
• Sinusitis
• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Fluoroquinolone (FQ)	Participants exposed to an oral FQ will be observed. The oral FQ included are Levofloxacin, Ciprofloxacin, Moxifloxacin, Ofloxacin, Gemifloxacin. Participants will not receive any intervention as a part of this study.
DRUG	Azithromycin (AZ)	Participants exposed to an oral AZ will be observed. Participants will not receive any intervention as a part of this study.
DRUG	Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination	Participants exposed to an oral ST will be observed. Participants will not receive any intervention as a part of this study.

Timeline

• Start date: 2018-05-17
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-05-24
• Last updated: 2019-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study